Medical Device Analyzer Software Causes Motor Control Error and Result Delays
Beckman Coulter's DxI 600 Access Immunoassay Analyzer has a software issue causing incorrect motor current settings that lead to motion errors and potential delays in patient sample reporting. The recall affects 177 systems worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This Class II medical device recall involves a software-induced motor control malfunction that could delay critical patient test results. However, no illnesses, injuries, or adverse events have been reported, and the issue is detectable and correctable once identified.
Plain-English summary
The Beckman Coulter DxI 600 Access Immunoassay Analyzer (Part Number A71460) is being recalled due to a software defect. The device's pick-and-place (PnP) gantry system with software versions 5.7 and higher contains an error where the X-motor current setting incorrectly resets to 1.5 amperes instead of the required 2.0 amperes. This occurs when the software is installed or upgraded, as the software overwrites the correct factory setting.
This incorrect motor current setting causes increased motion errors in the analyzer's sample handling system. According to the manufacturer, these errors could lead to delays in reporting patient sample test results if the issue goes undetected. The recall affects 177 analyzer systems distributed worldwide.
The affected systems are identified by part number A71460 and specific serial numbers provided in the recall notice. The systems run software versions 5.7 and higher. Facilities operating affected devices should contact Beckman Coulter for further guidance.
The recalled product
- Product
- DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- software-malfunction
- motor-control-error
- result-reporting-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 15099590369224
Distribution
Distributed nationwide across the United States.
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